Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00668239
First received: April 24, 2008
Last updated: April 28, 2008
Last verified: April 2008

April 24, 2008
April 28, 2008
September 2004
April 2006   (final data collection date for primary outcome measure)
diffuse macular oedema [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00668239 on ClinicalTrials.gov Archive Site
morphofunctional assessment of retina [ Time Frame: 1,3 and 6 monts ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser
Treatment of Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone and Laser Photocoagulation: Randomized Clinical Trial With Morphological and Functional Evaluation

This study compares the use of intravitreous triamcinolone and laser therapy to treat maculopahty in patients with type 2 diabetes mellitus in a short-tem period of 6 months

The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular oedema with intravitreal triamcinolone and laser in patients with type 2 diabetes mellitus (DM), using a morphofunctional assessment. Patients with clinically significant diffuse macular oedema, previously untreated and with a macular thickness >250 μm at optical coherence tomography (OCT) were randomized for treatment with Laser or intravitreal injection of Triamcinolone acetate. Optical coherence tomography (OCT), biomicroscopy, fundoscopy, fluorescein angiography, tonometry, scotometry, visual acuity and contrast acuities were performed at 0, 1, 3 and 6 months.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Macular Edema
  • Drug: intravitreous triamcinolone
    Intravenous injection of 0.1 ml (4 mg) of triamcinolone acetate was performed through the pars plana in a surgical environment. The medication used was manipulated by the Ophthalmos chemist. This type of formulation is different from the similar American one (Kenalog ®) since it does not use a conservation agent
  • Procedure: laser therapy
    pan fotocoaglulation by laser therapy
  • Active Comparator: 1
    Laser treatment: laser was applied to the macular region according to the modified grid technique in inverted C, preserving 500 μ of the foveolus and avascular zone, with 100μ diameter shots, energy varying from 0.2 to 0.5 joules, with a time of exposure between 0.2 and 0.4 seconds. One hundred and fifty to 200 shots were applied according to the size of the retinal area². ND YAG laser (Crystal Focus (EMERED®) was used
    Intervention: Procedure: laser therapy
  • Experimental: 2
    triamcinolone as previously described
    Intervention: Drug: intravitreous triamcinolone
Gil AL, Azevedo MJ, Tomasetto GG, Muniz CH, Lavinsky J. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation. Arq Bras Oftalmol. 2011 Sep-Oct;74(5):343-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
June 2006
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with type 2 DM, diffuse macular oedema secondary to diabetic retinopathy, seen at the Centre of Reference for Diabetic Retinopathy at Hospital de Clinicas de Porto Alegre (HCPA) and at the Ophthalmology Outpatient Clinic at HCPA,

Exclusion Criteria:

  • patients with type 2 DM and previous treatment of diffuse macular oedema secondary to diabetic retinopathy
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00668239
HCPA-04288
No
MIrela Jobim de Azevedo
Hospital de Clinicas de Porto Alegre
Not Provided
Principal Investigator: Alberto L Gil, MD UFRGS
Hospital de Clinicas de Porto Alegre
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP